Group Leader, Production (Nights)

1) Day-to-day direction of line operators.

2) Cleaning, loading the commodities, setup, size changeover, startup activities, and the normal operation of the batch.

3) Coordinates, with the supervisor, the scheduling adherence of production and other functions such as, but not limited to validation, engineering, automation, and microbiology.

4) Performs maintenance, troubleshoots, and performs preventative maintenance of production lines.

5) Perform peer to peer batch record documentation review throughout the shift to ensure documentation is accurate and in alignment to the Good Documentation Practice standards and ensures the close out of batch records prior to supervisor review.

6) Ensures that the cleanings and preventive maintenance of equipment, per procedures, are being completed on time.

7) Promotes safety and teamwork through concise communication with co-workers and leaders.

8) Subject Matter Expert of the set-up, operation, and troubleshooting of the Integrated Bag Making Filling Machine (IBFM), Robot Cell Overwrap equipment (RCO) and Overwrap Machine to ensure minimal downtime is encountered.

9) Required to operate advanced HMI applications.

10) Adept at problem solving. Specifically, to identify problem, developing solution, and execute corrections while adhering to all applicable SOPs.

11) Documenting work accurately and in a timely manner in the batch record and/or logbooks.

12) Adheres to SOP's, cGMP's, and Safety Requirements.

13) Responsible for ensuring the compliance to company documents, programs and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per your roles and responsibilities.

14) Back-up for the supervisor as needed for SAP transactions, investigations, and review/completion of Batch Records.

15)Ensures that all employees are following safety, cGMP and department policies and procedures. Communicates issues or non-compliance to supervisor when necessary.

16) Performs other duties as assigned by management.

• High school diploma
• Mechanical aptitude required regarding automated equipment.
• Minimum of5+ years of experience in a regulated industry.
• Must be able to communicate in a very efficient and clear manner.
• Must be able to lift 50 pounds with assistance.
• Must be able to wear personal protective equipment.
• Must work overtime as necessary to support production (weekday and weekends).

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability,401K with company contribution, andwellness program.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.